Validating Dozee for Contactless Monitoring of Heart, Breathing, and Movemen

NCT ID: NCT07223931

Last Updated: 2025-11-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-16
• Study Completion Date: 2025-12-31

Brief Summary

The Dozee VS system (K221555) is a contactless device that tracks heart rate and breathing rate using a sensor sheet placed under the mattress. It captures body vibrations and converts them into vital signs, which can be monitored remotely in real time. The system also supports add-ons like a blood pressure cuff, pulse oximeter, and thermometer, offering a complete monitoring solution. This study aims to validate the updated AI-powered heart rate and improved breathing rate algorithms across different sensor sheet types to confirm clinical accuracy

Detailed Description

The Dozee VS system (K221555), developed by Turtle Shell Technologies, is a non-invasive, contactless device that continuously monitors heart rate (HR) and breathing rate (RR). A thin sensor sheet placed under the mattress detects tiny body vibrations from the heart and lungs, which are processed by smart algorithms and displayed on a secure online dashboard for real-time monitoring.

Unlike traditional methods such as ECGs, nasal tubes, or thermistors-which are invasive, require skilled placement, and are uncomfortable for long-term use-Dozee is simple, comfortable, and doesn't rely on patient compliance like wearables do. The system can also connect to add-on devices, including a blood pressure cuff, pulse oximeter, and thermometer, giving a full picture of a patient's vital signs and helping spot early signs of deterioration.

Hardware upgrades now include dual-sensor sheets that improve accuracy across different mattresses and patient types. The new HR algorithm uses AI/ML for better accuracy, while the improved RR algorithm performs more reliably even with movement or weak signals.

Study Goal: This study aims to validate the updated algorithms (Gen 2) for HR and RR across the three sensor sheet types (DS, S1, and S1-I) to ensure they meet clinical accuracy standards

Conditions

No Specific Medical Conditions or Disease States; No Specific Conditions

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Single Arm Study (Cohort)

Group/Cohort Description: All participants will be on standard telemetry monitoring for Heart Rate and Respiration Rate using the gold standard (Electrocardiography and Capnography respectively). In addition, a contactless monitoring devices will be placed on the patient bed to measure data. This device is Dozee VS (Investigational Device). Data from all devices will be measured simultaneously.

Device: Telemetry monitoring

Intervention Type: DEVICE

All participants will be on standard telemetry monitoring for Heart Rate, Respiration Rate and movements using the gold standard (Electrocardiography and Capnography respectively).

Interventions

Device: Telemetry monitoring

All participants will be on standard telemetry monitoring for Heart Rate, Respiration Rate and movements using the gold standard (Electrocardiography and Capnography respectively).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Adults Male or female. (Above 18 years of age)

2. Provide written informed consent.

3. Weight between 40kg/88.18lbs and 120kg/264.55lbs

4. Agree to not eat during the testing period

5. Able to move and exit the bed independently and safely.

1. Are connected to a device that may interfere with the device monitoring in this study.

2. Are receiving any bedside care which may be incompatible with the study procedures.

3. A likely need to receive or undergo a procedure during the testing period.

4. Cannot accept a nasal cannula, or have an ECG leads placed on the chest.

5. Have a significant medical condition in the judgement of the investigator, which may compromise the study testing procedures.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eastside Research Associates

UNKNOWN

Sponsor Role: collaborator

Turtle Shell Technologies Pvt. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sapna Chilka, MD

Role: PRINCIPAL_INVESTIGATOR

ERA Health Research

Locations

ERA Health Research

Midland, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Hinali Zhaveri

Role: CONTACT

hzaveri@erahealthresearch.com

559-554-2265

Other Identifiers

DZ_VS_VAL

Identifier Type: -

Identifier Source: org_study_id